Reducing Risk for Infective Endocarditis (PIE-B)
Bacteremia, Infective Endocarditis
About this trial
This is an interventional prevention trial for Bacteremia focused on measuring Oral Hygiene, Oral Bacteria, Gingival inflammation
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. Greater than 6 months since last dental hygiene prophylaxis (cleaning). 10 or more accessible teeth (including implants, with a minimum of 8 natural teeth). Willing and able to provide informed consent. Willing to comply with all study procedures and be available for the duration of the study. Willing to forgo routine professional dental cleanings while enrolled in the trial. Exclusion Criteria: At high risk for IE, as defined by the 2007/2021 AHA Guidelines: Prosthetic cardiac valve or prosthetic material used for cardiac valve repair. Previous episode of IE. Cardiac transplantation recipient with cardiac valvulopathy. Specific congenital heart disease conditions. Pregnant, by self-report, or planning to become pregnant during the study period. Affected by a condition that, in the opinion of the investigator, may preclude them from study completion or put them at increased risk such as : Hemodialysis dependent. Have a long-term intravascular catheter (e.g., for chemotherapy or parenteral nutrition). Active injection drug use (IDU). Clotting disorder such as, hemophilia. Have a solid organ transplant or hematopoietic stem cell transplant, or ongoing treatment for hematologic cancer. Currently incarcerated. Systemic antibiotic use within the past 2 weeks. Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plans to do so during the study period. Taking or requiring antibiotic prophylaxis prior to dental procedures for other reasons, e.g., to prevent prosthetic joint infection . Three or more teeth with moderate to severe gingival hyperplasia. Has clinically detectable emergent or urgent dental needs that, in the trained and calibrated Oral Examiner's opinion, would require definitive dental care during the study period.
Sites / Locations
- Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
- Brigham and Women's Hospital
- University of Michigan School of Dentistry and Michigan Medicine
- University of Rochester Medical Center
- Atrium Health's Carolinas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Participants receiving a dental cleaning and oral hygiene instruction
Control
Participants randomized to this arm will receive a standard dental cleaning and education on proper toothbrushing and flossing technique and asked to follow these toothbrushing and flossing techniques for the duration of the study period. They will receive periodic phone call reminders to maintain these practices during the study period.
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.